Microwave ablation devices including expandable antennas and methods of use

ABSTRACT

A microwave ablation device for treating tissue includes an inner conductor having a length and a distal end and configured to deliver energy, a wire extending adjacent the inner conductor and axially translatable relative thereto, the wire including a length and a distal end, a distal tip disposed in mechanical cooperation with the distal end of the inner conductor and the distal end of the wire, and an outer conductor including a distal end and defining a longitudinal axis, the outer conductor at least partially surrounding the inner conductor and the wire at least partially along their lengths. The distal tip is movable substantially along the longitudinal axis with respect to the outer conductor and relative movement of the distal tip towards the distal end of the outer conductor causes at least a portion of the inner conductor to move away from the longitudinal axis.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.12/413,011 filed on Mar. 27, 2009, which claims priority to U.S.Provisional Application No. 61/039,851 filed on Mar. 27, 2008, thecontents of each of which is incorporated herein by reference.

BACKGROUND Technical Field

The present disclosure relates to microwave ablation devices andmethods. More particularly, the disclosure relates to microwave antennasthat are insertable into tissue and capable of being expanded.

Background of Related Art

In the treatment of diseases such as cancer, certain types of cancercells have been found to denature at elevated temperatures that areslightly lower than temperatures normally injurious to healthy cells.These types of treatments, known generally as hyperthermia therapy,typically utilize electromagnetic radiation to heat diseased cells totemperatures above 41° C. while maintaining adjacent healthy cells atlower temperatures where irreversible cell destruction will not occur.Other procedures utilizing electromagnetic radiation to heat tissue alsoinclude ablation and coagulation of the tissue. Such microwave ablationprocedures, e.g., such as those performed for menorrhagia, are typicallydone to ablate and coagulate the targeted tissue to denature or kill it.Many procedures and types of devices utilizing electromagnetic radiationtherapy are known in the art. Such microwave therapy is typically usedin the treatment of tissue and organs such as the prostate, heart, andliver.

One non-invasive procedure generally involves the treatment of tissue(e.g., a tumor) underlying the skin via the use of microwave energy. Themicrowave energy is able to non-invasively penetrate the skin to reachthe underlying tissue. However, this non-invasive procedure may resultin the unwanted heating of healthy tissue. Thus, the non-invasive use ofmicrowave energy requires a great amount of control. This is partly whya more direct and precise method of applying microwave radiation hasbeen sought.

Presently, there are several types of microwave probes in use, e.g.,monopole, dipole, and helical. One type is a monopole antenna probeconsisting of a single, elongated microwave conductor exposed at the endof the probe. The probe is sometimes surrounded by a dielectric sleeve.The second type of microwave probe commonly used is a dipole antennaconsisting of a coaxial construction having an inner conductor and anouter conductor with a dielectric separating a portion of the innerconductor and a portion of the outer conductor. In the monopole anddipole antenna probe, microwave energy generally radiatesperpendicularly from the axis of the conductor.

Because of the perpendicular pattern of microwave energy radiation,conventional antenna probes are typically designed to be inserteddirectly into the tissue, e.g., a tumor, to be radiated. However, suchtypical antenna probes commonly fail to provide uniform heating axiallyand/or radially about the effective length of the probe.

It is often difficult to assess the extent to which the microwave energywill radiate into the surrounding tissue, i.e., it is difficult todetermine the area or volume of surrounding tissue that will be ablated.Furthermore, when conventional microwave antennas are inserted directlyinto the tissue, e.g., cancerous tissue, there is a danger of draggingor pulling cancerous cells along the antenna body into other parts ofthe body during insertion, placement, or removal of the antenna probe.

One conventional method for inserting and/or localizing wires or guidesincludes a wire guide that is delivered into breast tissue, for example,through a tubular introducer needle. When deployed, the wire guide cutsinto and scribes a circular path about the tissue distal to a lesionwhile the remainder of the distal portion of the wire guide follows thepath scribed by the distal tip and locks about the tissue.

In certain circumstances, it is advantageous to create a relativelylarge ablation region, which often requires multiple ablationinstruments to be inserted into a patient. It would therefore bedesirable to provide a single instrument that can be used to create arelatively large ablation region.

SUMMARY

A microwave ablation device for treating tissue includes an innerconductor having a length and a distal end and configured to deliverenergy, a wire extending adjacent the inner conductor and axiallytranslatable relative thereto, the wire including a length and a distalend, a distal tip disposed in mechanical cooperation with the distal endof the inner conductor and the distal end of the wire, and an outerconductor including a distal end and defining a longitudinal axis, theouter conductor at least partially surrounding the inner conductor andthe wire at least partially along their lengths. The distal tip ismovable substantially along the longitudinal axis with respect to theouter conductor and relative movement of the distal tip towards thedistal end of the outer conductor causes at least a portion of the innerconductor to move away from the longitudinal axis.

The inner conductor may arc away from the longitudinal axis in responseto the relative movement of the distal tip with respect to the distalend of the outer conductor, and at least a portion of the innerconductor may be flexible. Also, at least a portion of the innerconductor may be configured to pierce tissue.

A corner may be formed on the inner conductor in response to movement ofthe distal tip with respect to the distal end of the outer conductor,and this corner may be uninsulated.

In some embodiments, the microwave ablation device may further includeat least a second inner conductor, the second inner conductor includinga length and a distal end and connected to the distal tip adjacent thedistal end thereof.

In some embodiments, the distal tip is configured to pierce tissue andis electrically coupled to the distal tip.

In some embodiments, relative movement of the distal tip away from thedistal end of the outer conductor causes at least a portion of the innerconductor to move towards the longitudinal axis.

In some embodiments, a dielectric material may be disposed between theouter conductor and the inner conductor.

In some embodiments, the inner conductor is an expandable mesh.

DESCRIPTION OF THE DRAWINGS

Embodiments of the presently disclosed microwave ablation devices aredisclosed herein with reference to the drawings, wherein:

FIG. 1 is a perspective view of a microwave ablation device inaccordance with an embodiment of the present disclosure;

FIG. 2 is a schematic view of the microwave ablation device of FIG. 1connected to a generator;

FIG. 3 is a cross-sectional view of a portion of a feedline of themicrowave ablation device of FIGS. 1 and 2, as taken through 3-3 of FIG.2;

FIG. 4 is a side view of a distal portion of the microwave ablationdevice of FIG. 1-3;

FIG. 5 is a perspective view of the distal portion of the microwaveablation device of FIGS. 1-4;

FIG. 6 is a side view of a distal portion of the microwave ablationdevice of FIG. 1 in a first stage of deployment, in accordance with anembodiment of the present disclosure;

FIG. 7 is a distal end view of the distal portion of the microwaveablation device of FIGS. 1 and 6;

FIG. 8 is a perspective view of the distal portion of the microwaveablation device of FIGS. 1, 6 and 7 in a second stage of deployment;

FIGS. 9 and 10 are sides views of a distal portion of a microwaveablation device in accordance with another embodiment of the presentdisclosure illustrating various stages of deployment thereof; and

FIGS. 11 and 12 are side views of a distal portion of a microwaveablation device in accordance with another embodiment of the presentdisclosure illustrating various stages of deployment thereof.

DETAILED DESCRIPTION OF EMBODIMENTS

Embodiments of the presently disclosed microwave ablation devices aredescribed in detail with reference to the drawings, in which likereference numerals designate identical or corresponding elements in eachof the several views. As used herein the term “distal” refers to thatportion of the microwave ablation device, or component thereof, fartherfrom the user while the term “proximal” refers to that portion of themicrowave ablation device or component thereof, closer to the user.

An ablation device (e.g., a microwave ablation device) in accordancewith the present disclosure is referred to in the figures as referencenumeral 10. Referring initially to FIG. 1, microwave ablation device 10includes a microwave antenna 12 and a handle portion 13. Microwaveantenna 12 includes a shaft or feedline 14 having at least one innerconductor 16, a wire 18 and an outer structure 20, which defines alongitudinal axis X-X. A power transmission cord 21 is shown to connectmicrowave ablation device 10 to a suitable electrosurgical generator 22(see FIG. 2). Additionally, an actuation element 7 is illustrated inFIG. 1 in accordance with various embodiments of the present disclosure.

As seen in FIG. 2, each inner conductor 16 extends from feedline 14 anda penetrating tip 30 is disposed adjacent to or coupled to a distal endof each inner conductor 16. In the illustrated embodiment, the proximalend of feedline 14 includes a coupler 19 that electrically couplesantenna 12 to generator 22 via power transmission cord 21.

It is envisioned that microwave ablation device 10 may be introduced tothe treatment site via a straight, arcuate, non-deployable and/ordeployable applicator or introducer. It is further envisioned that tip30 is configured to pierce tissue to facilitate introduction ofmicrowave ablation device 10 to the treatment site.

As described above and as shown in FIG. 3, feedline 14 may be in theform of a coaxial cable. Portions of feedline 14 may be formed of anouter structure 20 (e.g., an outer conductor) surrounding at least oneinner conductor 16. Each inner conductor 16 and/or outer structure 20may be made of a suitable conductive metal that may be semi-rigid orflexible, such as, for example, copper, gold, or other conductive metalswith similar conductivity values. Alternatively, portions of each innerconductor 16 and outer structure 20 may also be made from stainlesssteel that may additionally be plated with other materials, e.g., otherconductive materials, to improve their properties, e.g., to improveconductivity or decrease energy loss, etc.

For example, inner conductors 16 may be made of stainless steel havingan impedance of about 50Ω. In order to improve a conductivity of astainless steel inner conductor 16, inner conductor 16 may be coatedwith a layer of a conductive material such as copper or gold. Althoughstainless steel may not offer the same conductivity as other metals, itdoes offer increased strength required to puncture tissue and/or skin.

With continued reference to FIG. 3, feedline 14 of antenna 12 is shownincluding a dielectric material 28 surrounding at least a portion of alength of each inner conductor 16 and outer structure 20 surrounding atleast a portion of a length of dielectric material 28 and/or each innerconductor 16. That is, a dielectric material 28 is interposed betweeninner conductor 16 and outer structure 20, to provide insulationtherebetween and may be comprised of any suitable dielectric material.

Various embodiments of a distal portion 22 of microwave ablation device10 are shown in FIGS. 4-12. With specific reference to FIGS. 4 and 5,distal portion 22 of microwave ablation device 10 includes at least oneinner conductor 16 (e.g., three inner conductors 16 a, 16 b and 16 cbeing shown in FIG. 5), a wire 18, an outer structure or conductor 20and a distal tip 30. Distal tip 30 is in mechanical cooperation witheach inner conductor 16 and wire 18 and is movable with respect to outerstructure or conductor 20. In some embodiments, distal tip 30 is also inelectrical communication with each inner conductor 16 and wire 18.

It is envisioned that translation of actuation element 7 (see FIG. 1)causes movement of distal tip 30 (substantially along longitudinal axisX-X) with respect to outer structure or conductor 20. Moreover, distaltranslation of actuation element 7 causes distal tip 30 to move distallyin the direction of arrow “A” and proximal translation of actuationelement 7 causes distal tip 30 to move proximally in the direction ofarrow “B.” It is also contemplated that distal translation of actuationelement 7 may cause outer structure 20 to move distally in the directionof arrow B and proximal translation of actuation element 7 may causeouter structure 20 to move proximally in the direction of arrow A.

In response to the relative movement between outer structure orconductor 20 and distal tip 30, at least a portion of each innerconductor 16 is forced radially away from longitudinal axis X-X, in thedirection of arrows “C” and/or “D” (see FIG. 5). Thus, an ablationregion 40, as defined by the boundaries of inner conductors 16 a, 16 b,16 c (including the area between inner conductors 16 a, 16 b, 16 c andadjacent wire 18), is expanded (e.g., widened) as a distance betweenouter structure or conductor 20 and distal tip 30 becomes smaller. Inthe embodiment illustrated in FIGS. 4 and 5, inner conductors 16 a, 16b, 16 c arc away from longitudinal axis X-X. In such an embodiment, itis envisioned that at least a portion of each inner conductor 16 isflexible.

Each inner conductor 16 may be configured to pierce or slice throughtissue, either mechanically and/or with the aid of energy, e.g.,radiofrequency energy. In the embodiment where inner conductor(s) 16 canmechanically pierce or slice through tissue, inner conductor(s) 16 maybe thin enough to pierce or slice through tissue upon the exertion of apredetermined amount of force (e.g., the amount of force created whenouter structure or conductor 20 and distal tip 30 are approximated).Additionally or alternatively, inner conductor(s) 16 may be configuredto receive energy, e.g., from a generator, to piece or slice throughtissue or assist in piercing or slicing through tissue.

Another embodiment of microwave ablation device 10 is illustrated inFIGS. 6-8. Here, upon decreasing the distance between outer structure 20and distal tip 30, inner conductors 16 d, 16 e, 16 f move away fromlongitudinal axis X-X, such that each inner conductor 16 d, 16 e, 16 fforms a corner, point or bend 17 d, 17 e, 17 f, respectively (as opposedto forming an arc-like shape as shown in FIGS. 4 and 5).

It is envisioned that insulation 50 may be disposed on at least aportion of inner conductors 16 of the various embodiments disclosedherein. For example, as seen in FIGS. 6-8, inner conductors 16 d, 16 e,16 f include insulation 50 along at least a portion of their lengths anddefine a respective uninsulated or exposed portion 52 d, 52 e, 52 f(e.g., adjacent and/or including bends 17 d, 17 e, 17 f).

In the embodiment illustrated in FIGS. 9 and 10, inner conductor 16 isin the form of an expandable mesh 60. Here, expandable mesh 60 extendsbetween outer structure or conductor 20 and distal tip 30 and definesablation region 40 therebetween. Upon relative movement of distal tip 30and outer structure or conductor 20, at least a portion of expandablemesh 60 moves or deflects away from wire 18 (as shown by arrows “E” and“F” in FIG. 10). Expandable mesh 60 may be configured to deliver energy,e.g., radiofrequency, ultrasound, cryotherapy energy, laser energyand/or microwave energy to the target tissue.

In the embodiment illustrated in FIGS. 11 and 12, inner conductor 16 isin the form of an expandable sheath 70. In this embodiment, expandablesheath 70 (e.g., including a polymeric material) is used to create ordefine ablation region 40. Expandable sheath 70 may be filled orinflated with a conductive material, a dielectric material or acombination thereof. Upon relative movement between distal tip 30 andouter structure 20, at least a portion of expandable sheath 70 movesaway from wire 18 (as shown by arrows “G” and “H” in FIG. 12).Expandable sheath 70 may be configured to deliver energy, e.g.,radiofrequency, ultrasound, cryotherapy energy, laser energy and/ormicrowave energy.

A method of treating tissue using ablation device 10 is also included bythe present disclosure. The method may include at least providing anmicrowave ablation device, such as ablation device 10 described above,inserting at least a portion of the ablation device into a targetsurgical site while in a collapsed condition, moving a distal tip of theablation device to cause at least a portion of an inner conductor tomove away from a longitudinal axis thereof, and delivering energy to thetarget surgical site via at least a portion of the inner conductor. Themethod may further include moving a distal tip of the ablation device tocause at least a portion of an inner conductor to move towards thelongitudinal axis thereof, and withdrawing the ablation device from thetarget surgical site. The method may further include energizing at leasta portion of the ablation device during insertion of the portion of theablation device into the target surgical site.

It will be understood that various modifications may be made to theembodiments disclosed herein. Therefore, the above description shouldnot be construed as limiting, but merely as exemplifications of variousembodiments. Those skilled in the art will envision other modificationswithin the scope and spirit of the claims appended hereto.

1-20. (canceled)
 21. An electrosurgical device, comprising: a wiredefining a longitudinal axis; an outer conductor at least partiallysurrounding the wire; a distal tip portion coupled to the wire, the wireconfigured to move the distal tip portion along the longitudinal axis;and an inner conductor at least partially surrounded by the outerconductor and having an insulated portion and an uninsulated portion,the inner conductor configured to move away from the longitudinal axisupon movement of the distal tip portion along the longitudinal axis toform a bend at the uninsulated portion of the inner conductor fortreating tissue.
 22. The electrosurgical device according to claim 21,wherein the uninsulated portion is surrounded by the insulated portion.23. The electrosurgical device according to claim 21, wherein the innerconductor is configured to be disposed orthogonal to the longitudinalaxis upon movement of the distal tip portion along the longitudinalaxis.
 24. The electrosurgical device according to claim 21, furthercomprising a plurality of inner conductors radially spaced from eachother about the longitudinal axis.
 25. The electrosurgical deviceaccording to claim 21, wherein the electrosurgical device is a microwaveantenna configured to deliver microwave energy to tissue.
 26. Theelectrosurgical device according to claim 21, further comprising adielectric material disposed between the inner and outer conductors andsurrounding at least a portion of the wire.
 27. The electrosurgicaldevice according to claim 21, wherein the distal tip portion iselectrically coupled to the wire.
 28. The electrosurgical deviceaccording to claim 21, wherein the distal tip portion includes a tapereddistal tip configured to pierce tissue.
 29. The electrosurgical deviceaccording to claim 21, wherein the inner conductor is configured topierce tissue.
 30. The electrosurgical device according to claim 21,wherein the distal tip portion is configured to move along thelongitudinal axis toward a distal end of the outer conductor to move theinner conductor away from the longitudinal axis.
 31. The electrosurgicaldevice according to claim 21, wherein the wire is configured to movealong the longitudinal axis relative to the outer conductor.
 32. Theelectrosurgical device according to claim 21, wherein the distal tipportion is mechanically and electrically connected to a distal end ofthe inner conductor and a distal end of the wire.
 33. Theelectrosurgical device according to claim 21, wherein the bend dividesthe uninsulated portion to include a proximal-facing surface and anopposing distal-facing surface.
 34. The electrosurgical device accordingto claim 21, wherein the insulated portion includes a first insulatedsurface extending proximally from a first end of the uninsulated portionand a second insulated surface extending distally from a second end ofthe uninsulated portion to the distal tip portion.
 35. Anelectrosurgical device, comprising: a feedline defining a longitudinalaxis, the feedline including: an inner conductor configured to treattissue and having an insulated portion and an uninsulated portion; anouter conductor at least partially surrounding the inner conductor; anda dielectric material disposed between the inner and outer conductors;and a distal tip portion connected to the inner conductor and configuredto move along the longitudinal axis to move the inner conductor awayfrom the longitudinal axis such that the inner conductor forms a bend atthe uninsulated portion for treating tissue.
 36. The electrosurgicaldevice according to claim 35, further comprising a wire extending alongthe longitudinal axis and having a distal end connected to the distaltip portion, the wire configured to move the distal tip portion alongthe longitudinal axis.
 37. The electrosurgical device according to claim35, wherein the distal tip portion is mechanically and electricallyconnected to a distal end of the inner conductor.
 38. Theelectrosurgical device according to claim 35, wherein the bend dividesthe uninsulated portion to include a proximal-facing surface and anopposing distal-facing surface.
 39. The electrosurgical device accordingto claim 35, wherein the insulated portion includes a first insulatedsurface extending proximally from a first end of the uninsulated portionand a second insulated surface extending distally from a second end ofthe uninsulated portion to the distal tip portion.
 40. Theelectrosurgical device according to claim 35, wherein the uninsulatedportion is surrounded by the insulated portion.